Orcolon (Polyacrylamide)

No FDA recalls found in the data synced 6 Oct 2026.

Full name

Orcolon (R) (Polyacrylamide)

Generic Name

AID, SURGICAL, VISCOELASTIC

PMA Number

P900010 ↗

FDA Product Code

LZP

Device Class

Class III

Regulation

21 CFR Part 886.4275

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

PMA Supplement

S001 (Normal 180 Day Track)

• Orc Oracle

  Class I

  FDA 510(k) K853668 Active Cleared 15 Oct 1985

• Computon(R)

  Class II

  FDA 510(k) K863200 Active Cleared 3 Sep 1986

• 0R 160, Or-1.60, and Orcolite 1.60 High Index

  Class I

  FDA 510(k) K920795 Active Cleared 13 Jul 1992

• What is the Orcolon (R) (Polyacrylamide) used for in ophthalmic surgeries?

  The Orcolon (R) is designed as a surgical viscoelastic aid specifically for ophthalmic procedures. It helps maintain ocular integrity by providing viscosity and occupying space, which reduces trauma to ocular tissues and improves surgical access during eye surgeries.

• Is the Orcolon (R) reusable or single-use, and how should it be stored?

  The Orcolon (R) is supplied as a sterile, single-use product. To ensure safety and efficacy, it must be stored and handled according to sterile medical device protocols, just like any other sterile surgical aid.

• What regulatory pathway does the Orcolon (R) follow, and what is its PMA number?

  The Orcolon (R) is regulated under the FDA’s Premarket Approval (PMA) pathway with PMA number **P900010**. This classification applies to Class III devices, ensuring rigorous review before market authorization.

• Are there multiple sizes or models of the Orcolon (R), and how are they identified?

  Yes, the Orcolon (R) comes in multiple registration numbers (e.g., **3012236936**, **3011965331**, etc.), which correspond to different models or formulations. These identifiers are used in regulatory filings but do not directly indicate clinical variations—consult the manufacturer’s labeling for specific surgical applications.

• What recent changes have been made to the Orcolon (R) labeling, and why?

  A **Normal 180-Day Track supplement (S001)** was filed for a labeling change, covering updates to indications, instructions, shelf life, or the tradename. This ensures clinicians have the most current information for safe and effective use.